- Novo Nordisk Inc. (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creating business results with impact on VP/CVP level. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead (s), Global Safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …3 days in office and 2 days remote. Approximately 20-30% overnight travel. Global Job level: Director Development of People Ensure that reporting personnel ... with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an...market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …America and LATAM and other relevant stakeholders to ensure compliance with global recruitment process standards and regulatory requirements. Support TA teams' ... (KPIs) and Service Level Agreements (SLAs) Relationship Reports to a Director in the Global Talent Acquisition CoE, responsible for Global TA Strategy… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of successful alliances, ... from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support. Key internal relationships include brand marketing, market… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also interacts with other therapeutic area leaders and joint Alliance partners.Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...of Dx devices under design control process. They will lead identification and selection of Dx assays and partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … education, and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global...multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix environment in the pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development… more
